Obesity is a major health problem for many individuals. Many solutions for achieving the weight loss necessary to treat this problem have been proposed.
Common to many of these solutions is the requirement of the obese individual to decrease overall caloric intake and/or to increase energy output. One solution for reducing caloric intake may involve instructing the obese individual to consume foods which have a relatively low calorie to volume ratio, for example, low fat foods. Typically, however, this solution, by itself, is not sufficient for many overweight individuals because of an inability to select such foods for consumption. Oftentimes this is due to a lack of knowledge about nutrition and/or a lack of self-control.
In many cases vigorous exercise is recommended to achieve an increase in energy output. However, many overweight individuals, particularly, the morbidly obese, risk further damage to their health, for example, heart attacks, from such activity.
Other solutions involve the use of pharmaceuticals, for example, stimulative or appetite suppressive drugs. While this may be a satisfactory solution for many, the use of pharmaceuticals in the treatment of obesity is not without drawbacks. For example, individuals using such drugs are at risk of becoming addicted or ill-affected by side effects of the drugs. Further, these drugs oftentimes become less potent over time due to the development of a high drug tolerance.
Surgical solutions to the problem of obesity have also been proposed. Some of these procedures involve reducing the volume of the gastric cavity, for example, by creating a small pouch gastric bypass, or reducing the capacity of the stomach to expand, for example, by placing a constrictive band around the stomach. These surgical procedures are particularly traumatic to the body and are thus often associated with serious complications and increased mortality rates.
Thus, there continues to be a need for effective solutions to the problem of obesity.
Accordingly, it is first object of the present invention to provide an expandable body device for the gastric cavity and method.
It is a second object of the present invention to provide an improved expandable body device for the gastric cavity and method.
It is a third object of the present invention to provide an expandable body device for the gastric cavity and method of treating obesity.
It is a fourth object of the present invention to provide an expandable body device for the gastric cavity which is easily introduced to and removed from the gastric cavity.
It is a fifth object of the present invention to provide an expandable body device for the gastric cavity which may be introduced to and removed from the gastric cavity through a gastro-cutaneous fistula having a transverse cross-sectional profile which defines a relatively small area.
It is a sixth object of the present invention to provide an expandable body device for the gastric cavity which minimally contacts the inner surface of the gastric wall.
It is a seventh object of the present invention to provide an expandable body device for the gastric cavity which is prevented from moving relative to the individual in whose gastric cavity the device has been introduced.
It is an eighth object of the present invention to provide an expandable body device for the gastric cavity which includes an expandable body which is prevented from excessive movement while in the gastric cavity.
It is a ninth object of the present invention to provide an expandable body device for the gastric cavity which is comfortable for the person in whose gastric cavity the device has been introduced.
It is a tenth object of the present invention to provide an expandable body device for the gastric cavity which does not allow for gastric juices to escape from the gastric cavity.
It is an eleventh object of the present invention to provide an expandable body device for the gastric cavity which includes a minimum number of parts.
It is a twelfth object of the present invention to provide an expandable body device for the gastric cavity which is inconspicuous while in use.
It is a thirteenth object of the present invention to provide an expandable body device for the gastric cavity which is easy to manufacture.
It is a fourteenth object of the present invention to provide an expandable body device for the gastric cavity which is safe to use.
It is a fifteenth object of the present invention to provide an expandable body device for the gastric cavity which includes a small number of parts.
The present invention provides an expandable body device for the gastric cavity and method. The preferred embodiment of the present invention includes a rigid to semi-rigid fillant delivery tube having a base portion, an extending portion, and a tip portion. The fillant delivery tube is sealedly connected to an expandable body which is preferably constructed of surgical grade latex rubber. In a preferred embodiment, the extending portion and tip portion of the fillant delivery tube extend into the expandable body, which forms a substantially proximal and uniformly congruent layer thereover. An anchor and a valve are provided on the base portion of the fillant delivery tube.
To use a device constructed according to a preferred embodiment of the present invention for the treatment of obesity, a gastro-cutaneous fistula is established in the obese individual via a percutaneous endoscopic gastrostomy, a procedure well known to persons skilled in the art. The cross-sectional profile of the fistula tract is configured to correspond with the cross-sectional profile of the device along the expandable body.
Preferably, the fistula tract is allowed to mature (i.e. form scar tissue) over a period of from 1-2 weeks. Then, the device is brought into proximity of the fistula tract and a bio-compatible lubricant is applied to the device and/or to the fistula tract. The tip portion of the fillant delivery tube and the expandable body are placed at the entrance of the fistula tract and passed through the fistula by the application of a gentle force at the base portion of the fillant delivery tube. The anchor provides a convenient surface against which such a force may be applied.
The device is fully inserted when the anchor contacts the abdominal wall. The expandable body may then be expanded with a biocompatible fillant. A graduated syringe is loaded with an appropriate amount, typically 100-500 ml, of saline solution. The syringe is then sealedly engaged with the valve on the proximal end of the fillant delivery tube and the fillant is forced into the fillant delivery tube by depressing the syringe plunger, thereby causing the expandable body to expand within the gastric cavity. Once appropriate expansion size is reached, the tip of the syringe is removed from the valve which is preferably configured to seal upon withdrawal of the syringe.
The size of the of the expandable body is preferably configured so that when appropriate expansion size is reached, the expandable body occupies a substantial fraction of the total volume of the gastric cavity of the person in whose gastric cavity the device is introduced. This enables the individual to feel satiated or "full" after consuming a relatively small portion of food.
After a period of time, preferably 3 to 6 months, the syringe is again engaged with the valve. The plunger of the syringe is operated to create a vacuum condition in the syringe cylinder, thereby causing fillant to flow from the device into the syringe until the expandable body is returned to a non-expanded configuration. Once the expandable body is returned to a non-expanded configuration, the device may be re-filled, for example, to a new volume, or easily removed from the gastric cavity by simply pulling on the base portion of the flilant delivery tube.
Alternatively, a hose may be connected between a fillant supply pump and a valve on the fillant delivery tube. The valve is opened and a biocompatible fillant, for example, air or saline, is pumped through the valve and into the filiant delivery tube. The fillant goes through the fillant delivery tube and enters the expandable body causing the expandable body to expand within the gastric cavity. After a period of time, the hose is again connected to the valve. Upon opening of the valve, the force of the elastic expandable body forces fillant from the expandable body into the fillant delivery tube and out of the device. Thereafter, the device may be re-filled with fillant or easily removed from the gastric cavity by simply pulling on the base portion of the fillant delivery tube.
While the function of the present invention to provide a deterrent to the consumption of food is easily appreciated, it is important to realize that the present invention allows this benefit to be realized with a lower risk of health problems, smaller loss of healthy social activity, and lower monetary cost than known methods of treating obesity.
To begin, the fillant delivery tube is preferably provided with a tapering, closed tip portion having a rounded distal end which is easily placed at the opening of the fistula by sliding the tip portion along the abdomen until the rounded distal end engages the entrance of the fistula tract. During insertion, the tip portion gently and gradually forces open the fistula to accommodate the fillant delivery tube.
Second, the rigid to semi-rigid fillant delivery tube preferably has a circular transverse cross-sectional profile and the ratio of the longitudinal length of the tube to the diameter thereof is relatively large. Thus, the is device easily translated through the fistula tract.
Third, the tip portion and the extending portion of the fillant delivery tube are covered by the expandable body which forms a single layer of material thereover. During insertion, the tissue of the fistula contacts only the relatively soft material of the expandable body. The device may be passed through a fistula tract having a transverse cross-sectional profile only slightly larger than the transverse cross-sectional profile of the device distal of the anchor.
Further, the expandable body expands within the gastric cavity such that contact with the gastric wall or lining is minimized (i.e. a space is maintained between substantially all surfaces of the expanded expandable body and the gastric wall). Since a tip portion of the fillant delivery tube is proximal to the internal surface of the spherically shaped expandable body, if the expandable body pivots slightly, it will contact the tip portion. Since these features prevent the expandable body from contacting the gastric wall and causing for example, ulcers, the device may be maintained in an expanded configuration within the gastric cavity for extended periods of time, preferably, three (3) to six (6) months.
The distance between the proximal surface of the expandable body and the distal surface of the anchor is preferably slightly smaller than the distance between the gastric entrance of the fistula tract and the surface of the abdomen proximal to the abdominal entrance of the fistula tract. Thus, as the expandable body expands, the proximal portion of the expandable body contacts the gastric entrance of the fistula tract which causes the anchor on the fllant delivery tube to which the expandable body is sealedly connected to abut the abdominal surface proximal to the fistula entrance. The associated compressive force causes the expandable body to sealingly contact the gastric entrance of the fistula tract, thus preventing the escape of gastric juices from the gastric cavity. The force also fixates the device relative to the individual in whose gastric cavity the device has been inserted. Thus, the present invention allows a morbidly obese person to remain active during treatment involving use of the present invention without fear of gastric juices leaking from the fistula tract or discomfort which could have been caused by shifting of the device.
Moreover, when the device of the present invention is inserted in the gastric cavity, the preferably disk shaped anchor mounted on the fillant delivery tube lies substantially flush with the surface of the abdomen and the base portion of the delivery tube and the valve mounted thereon protrudes only minimally, preferably, less than three (3) centimeters. The present invention is thus inconspicuous during use.
A device according to the present invention is also easy to manufacture. For example, an expandable body may be placed over a rigid to semi-rigid fillant delivery tube in a first manufacturing step. In a second manufacturing step, an integral anchor and valve component may be press-fit onto the proximal end of the fillant delivery tube to sealedly connect the fillant delivery tube to the expandable body and to mount the anchor and valve component to the proximal end of the fillant delivery tube.
Thus, the present invention provides a device which may be easily inserted into the gastric cavity through a gastro-cutaneous fistula having a relatively small transverse cross sectional profile. Further, an individual in whose gastric cavity the device has been introduced may remain active while the device is within the gastric cavity since the device prevents leakage of gastric juices from the fistula tract and otherwise does not present a threat of injury or discomfort to the individual. Use of a device according to the present invention also facilitates social activity since it is relatively inconspicuous while inserted in the gastric cavity. Moreover, since the fillant delivery tube inhibits the expandable body of the device from contacting the gastric wall, the expandable body may be maintained in an expanded configuration, within the gastric cavity for extended periods of time. Still further, the device of the present invention may be easily manufactured in, for example, as little as two steps. Thus, the present invention provides an expandable body device and method which are particularly useful in the treatment of obesity.